- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395830
Effects of a Multisensory VR Experience on Stress and User Experience
Effects of a Multisensory VR Experience on Stress and User Experience: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillermo Palacios, PhD
- Phone Number: +34978618179
- Email: guillermo.palacios@unizar.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- must meet the required age.
- must have corrected vision/hearing.
Exclusion Criteria:
- uncontrolled asthma.
- uncontrolled odor-triggered migraines.
- pregnancy state.
- nasal congestion.
- severe predisposition to dizziness in virtual reality.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control Group
|
|
|
Experimental: Experimental
Experimental Group
|
A 2×2 randomized design is used.
The Aroma condition is between subjects (relaxing aroma vs. no aroma) (experimental group and control group).
The Mode condition is within each group and consists of two blocks: Stress and Calm.
The order of the blocks is counterbalanced (Stress-Calm/Calm-Stress): half of the participants experience Stress first and then Calm, and the other half in the reverse order.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NASA Task Load Index
Time Frame: From enrollment to the end of treatment at 2 weeks
|
This test measures perceived mental workload. It has the following dimensions: Mental demand, effort, physical demand, performance, time constraints, and frustration level. Scoring interpretation: Higher scores for mental demand, effort, physical demand, time constraints, and frustration level indicate a greater workload/demand. Higher performance indicates a better experience. Reference: S. G. Hart y L. E. Staveland, "Development of NASA-TLX (Task Load Index): Results of Empirical and Theoretical Research", en Advances in Psychology, vol. 52, North-Holland, 1988, pp. 139-183. doi: 10.1016/S0166-4115(08)62386-9. |
From enrollment to the end of treatment at 2 weeks
|
|
Short Stress State Questionnaire (SSSQ)
Time Frame: From enrollment to the end of treatment at 2 weeks
|
Test to measure stress levels. It has three dimensions: engagement, anxiety, and worry. Scoring interpretation:
Reference: W. S. Helton y K. Näswall, "Short Stress State Questionnaire", Eur. J. Psychol. Assess., vol. 31, n.o 1, pp. 20-30, jun. 2015, doi: 10.1027/1015-5759/a000200. |
From enrollment to the end of treatment at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IPQ - Igroup Presence Questionnaire
Time Frame: From enrollment to the end of treatment at 2 weeks
|
A test that measures overall presence in VR. Dimensions: Spatial presence, engagement, realism. Scoring logic: Higher scores indicate greater presence. Reference: T. Schubert, F. Friedmann, and H. Regenbrecht, "The Experience of Presence: Factor Analytic Insights," Presence Teleoperators Virtual Environ., vol. 10, no. 3, pp. 266-281, June 2001, doi: 10.1162/105474601300343603. |
From enrollment to the end of treatment at 2 weeks
|
|
VRSQ - Virtual Reality Sickness Questionnaire
Time Frame: From enrollment to the end of treatment at 2 weeks
|
It measures Cybersickness / motion sickness symptoms. Dimensions: General malaise, vestibular symptoms. Scoring logic: Higher scores indicate greater malaise. Reference: H. K. Kim, J. Park, Y. Choi, and M. Choe, "Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment," Appl. Ergon., vol. 69, pp. 66-73, May 2018, doi: 10.1016/j.apergo.2017.12.016. |
From enrollment to the end of treatment at 2 weeks
|
|
VAS Scale
Time Frame: From enrollment to the end of treatment at 2 weeks
|
It measures:
Reference: M. Koo y S.-W. Yang, "Visual Analogue Scale", Encyclopedia, vol. 5, n.o 4, nov. 2025, doi: 10.3390/encyclopedia5040190. |
From enrollment to the end of treatment at 2 weeks
|
|
UEQ-S - User Experience Questionnaire Short
Time Frame: From enrollment to the end of treatment at 2 weeks
|
It masures the user experience. Dimensions: Pragmatic and hedonic. Scoring logic: Higher scores indicate better user experience. Reference: M. Schrepp, A. Hinderks, and J. Thomaschewski, "Design and Evaluation of a Short Version of the User Experience Questionnaire (UEQ-S)," Int. J. Interact. Multimed. Artif. Intell., vol. 4, no. 6, pp. 103-108, Dec. 2017. |
From enrollment to the end of treatment at 2 weeks
|
|
Performance rate
Time Frame: From enrollment to the end of treatment at 2 weeks
|
Measures of the number of correct answers, response time, and use of clues
|
From enrollment to the end of treatment at 2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UTI-VI-060-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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